FDA.reportPublic FDA data

Medline Industries, Inc.

Primary DI
40195327312580
Brand
Medline Industries, Inc.
Company
MEDLINE INDUSTRIES, INC.
Model
DYNJRA2106
Catalog number
DYNJRA2106
Device description
PARACERVICAL/PUDENDAL TRAY
Published
2023-01-01
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
OJHOrthopedic tray
PVVParacervical Anesthesia Kit

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OJHOrthopedic TrayGeneral, Plastic Surgery1
PVVParacervical Anesthesia KitObstetrics/Gynecology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
40195327312580PackageGS120In Commercial Distribution
10195327312589PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
4019532731258040195327312580
1019532731258910195327312589

GMDN Terms#

Term, Definition table
TermDefinition
General surgical procedure kit, non-medicated, single-useA typically non-dedicated collection of various surgical instruments, sometimes with dressings and/or other materials, but that does not contain pharmaceuticals, intended to be used during: 1) open abdominal surgery; 2) a range of open surgical procedures across multiple clinical specialties (non-dedicated); 3) non-orthopaedic trauma surgery; 4) minor dermatological surgery; or 5) cosmetic surgery below the head. As a kit that includes procedural devices, it is neither dedicated to surgical scrubbing, surgical patient preparation, nor anaesthesia, and is not a dedicated biopsy kit. This is a single-use device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)633-5463customerservice@medline.com

Regulatory Flags#

DUNS number
025460908
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
true
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10080196158652MEDLINE INDUSTRIES, INC.MDS139000MDS1390002026-07-16
10884389101551MEDLINEMDS160684MDS1606842016-10-14
10884389101575MEDLINEMDS160860MDS1608602016-10-14
10884389101674MEDLINEMDS160820MDS1608202016-10-14
10884389101704MEDLINEMDS160828MDS1608282016-10-14
10884389101728MEDLINEMDS160628MDS1606282016-10-14
10884389191613MEDLINEMDS160604MDS1606042016-10-14
10080196456765MEDLINEVDYND20302VDYND203022026-07-14
10080196031764MEDLINEDYND20125DYND201252026-07-13
10197344175963MEDLINEESS7012EPESS7012EP2026-07-13
10197344175970MEDLINEESS7022EPESS7022EP2026-07-13
10197344175987MEDLINEESS7044EPESS7044EP2026-07-13
10197344176007MEDLINEESS9022EPESS9022EP2026-07-13
10197344176014MEDLINEESS9045EPESS9045EP2026-07-13
10197344176021MEDLINEESS9048EPESS9048EP2026-07-13
10197344176038MEDLINEESS9066EPESS9066EP2026-07-13
10197344214723MEDLINEHCSLADYBUGSOLHCSLADYBUGSOL2026-07-13
20193489108214MEDLINEMDTZ1017073CAMDTZ1017073CA2026-07-13
20197344219435MEDLINEMDT2168056XGVMDT2168056XGV2026-07-13
20888277636559MEDLINEMDTZ1017073ABMDTZ1017073AB2026-07-13

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
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10198956368002CARDINAL HEALTHCardinal Health 200, LLCOJH2026-07-16
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10198956408401CARDINAL HEALTHCardinal Health 200, LLCOJH2026-07-16
10198956439726CARDINAL HEALTHCardinal Health 200, LLCOJH2026-07-16
10198956442450CARDINAL HEALTHCardinal Health 200, LLCOJH2026-07-16
10198956448308CARDINAL HEALTHCardinal Health 200, LLCOJH2026-07-16
10198956448483CARDINAL HEALTHCardinal Health 200, LLCOJH2026-07-16
10198956458291CARDINAL HEALTHCardinal Health 200, LLCOJH2026-07-16
10198956461512CARDINAL HEALTHCardinal Health 200, LLCOJH2026-07-16
10198956475328CARDINAL HEALTHCardinal Health 200, LLCOJH2026-07-16
10198956481367CARDINAL HEALTHCardinal Health 200, LLCOJH2026-07-16
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10198956487314CARDINAL HEALTHCardinal Health 200, LLCOJH2026-07-16
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10198956504776CARDINAL HEALTHCardinal Health 200, LLCOJH2026-07-16
10198956504806CARDINAL HEALTHCardinal Health 200, LLCOJH2026-07-16
10198956505490CARDINAL HEALTHCardinal Health 200, LLCOJH2026-07-16
10198956505704CARDINAL HEALTHCardinal Health 200, LLCOJH2026-07-16
10198956506909CARDINAL HEALTHCardinal Health 200, LLCOJH2026-07-16
10198956507685CARDINAL HEALTHCardinal Health 200, LLCOJH2026-07-16
10198956508019CARDINAL HEALTHCardinal Health 200, LLCOJH2026-07-16
10198956508170CARDINAL HEALTHCardinal Health 200, LLCOJH2026-07-16
10198956509382CARDINAL HEALTHCardinal Health 200, LLCOJH2026-07-16
10198956509603CARDINAL HEALTHCardinal Health 200, LLCOJH2026-07-16
10198956510418CARDINAL HEALTHCardinal Health 200, LLCOJH2026-07-16